ANDA Litigation Settlements

Spring 2016

GENERICally Speaking
Case Name Drug Patent No(s). Publicly Available Terms

Depomed, Inc. v. Endo Pharms. Inc., 13-2467 (D.N.J.)

Opana ER® (oxymorphone hydrochloride extended-release tablets)

6,340,475
6,635,280
6,723,340

N/A

In re: Certain Consolidated Zoledronic Acid Cases, 12-03967 (D.N.J.)

Reclast® (zoledronic acid)
Zometa® (zoledronic acid)

7,932,241
8,052,987
8,324,189

Novartis Pharms. Corp. and Actavis LLC agree to settle all claims that both parties have asserted against each other.

Acorda Therapeutics Inc. v. Par Pharm. Inc., 15-0824 (D. Del.)

Ampyra® (dalfampridine extended-release tablets)‎

8,007,826
8,354,437
8,440,703
8,663,685

Par agrees not to market its ANDA product in the U.S. until 2027. But there are certain circumstances that would allow Park to market its ANDA product earlier, though they are confidential.

Forest Labs. Inc. v. Apotex Corp., 13-1602 (D. Del.)

Savella® (milnacipran hydrochloride tablets)

6,602,911
7,888,342
7,994,220

Apotex is barred from selling any generic milnacipran hydrochloride product described in its ANDA before the three patents expire without first obtaining a license from Forest. Both parties also agreed to waive any right to an appeal and additionally agreed that all other claims against one another should be dismissed without prejudice.

Apotex Inc. v. Lupin Ltd., 15-0599 (E.D. Tex.)

Paxil® (paroxetine)

7,229,640
6,121,291

N/A

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